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Category Archives: Congtract Manufacturing

Therapeutic Peptides – Has This Emerging Market Grown Up?

Yes – The Peptide Drug Market Has Come of Age. Peptide drugs are not a new phenomenon by any stretch of the imagination. The first approved peptide-based drug – insulin…

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Planning for the Future: Evaluating a CMO’s Regulatory Capabilities

For those of you keeping your eye on regulatory matters, 2013 has the potential to be a big year as the FDA gears up to release new guidance on a…

Posted in CEP, Congtract Manufacturing, CRO/CMO, DMF, FDA, QA/QC, regulatory | Comments Off on Planning for the Future: Evaluating a CMO’s Regulatory Capabilities

Manufacturing Collaboration with Mitsubishi Healthcare Unit API Corporation

Some exciting news for Neuland Labs this week: we’ve just entered into a manufacturing collaboration with Tokyo-based API Corporation (APIC) – a healthcare unit of Mitsubishi Chemical Holdings Group. As…

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API Manufacture: Identifying & Controlling Genotoxic Impurities

Since API manufacturing plays a critical role during clinical development and after approval of a drug, familiarity with genotoxic impurities is an important issue for pharmaceutical firms considering outsourced API…

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